Exforge (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Exforge

GENERIC: amlodipine besylate and valsartan

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 52125-853-02

ACTIVE INGREDIENT(S):

  • AMLODIPINE BESYLATE 5mg in 1
  • VALSARTAN 160mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • POLYETHYLENE GLYCOLS
  • MAGNESIUM STEARATE
  • TALC
  • SILICON DIOXIDE
  • CROSPOVIDONE
  • FERRIC OXIDE YELLOW
  • HYPROMELLOSES
  • TITANIUM DIOXIDE

COLOR: yellow

SHAPE: OVAL

SCORE: No score

SIZE: 14 mm

IMPRINT: NVR;ECE

PACKAGING: 30 in 1 BOTTLE

MM3
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MM4
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EXFORGE amlodipine besylate and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-853(NDC:0078-0488)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
VALSARTAN (VALSARTAN) VALSARTAN 160 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
MAGNESIUM STEARATE
TALC
SILICON DIOXIDE
CROSPOVIDONE
FERRIC OXIDE YELLOW
HYPROMELLOSES
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL (TABLET, FILM COATED) Size 14mm
Flavor Imprint Code NVR;ECE
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52125-853-02 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021990 02/28/2014
Labeler — REMEDYREPACK INC. (829572556)

Revised: 02/2014 REMEDYREPACK INC.

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